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AURORA Phase 3 Study Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis

Cristina Arriens, Svetlana Polyakova, Igor Adzerikho, Simrat Randhawa, Neil Solomons for the AURORA Study Group

June 5, 2020

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Disclosures

Grant/Research Support

BMS: Investigator Initiated Trial Research Funding

GSK: Investigator Initiated Trial Research Funding

Exagen: Research Grant

Consulting Fees (advisory boards)

AstraZeneca

GSK

BMS

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Voclosporin: A Novel CNI

• Novel CNI developed as a structural change from cyclosporine A, incorporating a single carbon extension with a double-bond

• Voclosporin has a consistent dose response potentially eliminating the need for therapeutic drug monitoring

• 4x potency over cyclosporine A

Source: Aurinia. Data on file.

Potential disease-modifying podocyte stabilization, which protects against proteinuria

2Inhibition of calcineurin reduced cytokine activation of t-cells

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CNIs in Renal Disease: Two Separate Mechanisms of Action

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Aurinia Studies Evaluating Voclosporin in Active Lupus Nephritis

AURION(Proof of Concept)

• Single arm, twin center exploratory study

• Biomarkers at 8 weeks: 25% reduction in UPCR. C3/C4, anti-dsDNA normalization

• N = 7

• Primary analysis: # patients achieving biomarkers and # of these patients who go on to achieve Week 24 or Week 48 remission

Completed Trials

AURORA(Phase 3 RCT)

• Phase 3

• Double blind RCT

• N = 357

• Active control

• Primary endpoint: 52 week renal response

AURA-LV (Phase 2 RCT)

• Phase 2

• Double blind RCT

• N = 265

• Active control

• Primary endpoint: 24 week renal response

• Statistically significant result in active LN patients

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The AURORA Phase 3 Study Had Similar Inclusion Criteria and Primary Endpoints as AURA-LV Phase 2 Study

AURORA

Select Inclusion Criteria Primary Endpoint

Renal Response at Week 52

+ +eGFR ≥60 mL/min/1.73m2 or no confirmed

decrease from baseline in eGFR of ≥20%

+ +

+ +

Bold = change from AURA-LV

* Up to 2 years if accompanied by laboratory evidence of recent LN flare** Class V patients

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AURORA Phase 3 Study Design

VOCLOSPORIN 23.7 mg BID

MMF 2 g + oral corticosteroids

PLACEBO

MMF 2 g + oral corticosteroids

Primary endpoint52 weeks

Secondary endpoint24 weeks

1:1

Rand

omiza

tion

N =

357

2-Ye

ar E

xten

sion

St

udyTreatment Arm

Control Arm

Primary endpoint: Renal Response at Week 52

Abbreviations: BID = twice a day ; MMF = mycophenolate mofetil

• UPCR of ≤0.5 mg/mg• eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%• Presence of sustained, LD steroids (≤10mg pred. from Week 44-52)• No rescue medications

Rapid steroid taper from 20-25 mg/d Week 1 to 2.5 mg/d by Week 16

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p

22.5%

40.8%

Control Voclosporin 23.7 mg BID

AURORA Primary Efficacy Endpoint: Week 52 Renal Response (ITT)p < 0.001; OR: 2.65

N= 178 179

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Measure Result Odds Ratio [95% CI] p-value

Renal Response at 24 weeks Voclosporin 32.4%Control 19.7% 2.23 [1.34, 3.72] 0.002

Partial Renal Response at 24 weeks

Voclosporin 70.4%Control 50.0% 2.43 [1.56, 3.79] < 0.001

Partial Renal Response at 52 weeks

Voclosporin 69.8%Control 51.7% 2.26 [1.45, 3.51] < 0.001

Time to UPCR ≤ 0.5 mg/mg Voclosporin faster than Control

2.02 [1.51, 2.70]Hazard Ratio < 0.001

Time to 50% reduction in UPCR Voclosporin faster than Control

2.05 [1.62, 2.60]Hazard Ratio < 0.001

AURORA Hierarchical Secondary Endpoints (ITT)

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AURORA Secondary Endpoint: Time to UPCR < 0.5 mg/mg

Measure Result (Days) p-value

Median Time (50%) to UPCR < 0.5 mg/mg Voclosporin:169Control: 372 < 0.001

Median Time (25%) to UPCR < 0.5 mg/mg Voclosporin: 84Control: 127 < 0.001

0.00

0.25

0.50

0.75

1.00

0 25 50 75 100 125 150 175 200 225 250 275 300 325 350 375 400 425 450 475

Prob

abili

ty o

f UPC

R ≤

0.5

mg/

mg

Time (days)Voclosporin Placebo

+ censored observationLogrank p < 0.0001

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18.6%

52.5%

24.6%

50.8%

38.6%

68.4%

41.8%

70.5%

Control Voclosporin 23.7 mg BID

AURORA Renal Response, Partial Renal Response by Ethnicity

Hispanic(N = 116)

Non-Hispanic(N = 240)

p = 0.006 p = 0.060 p = 0.005 p = 0.002

RR PR RR PR

N= 59 57 59 57 122118 122118

RR: Renal Response, PR: Partial Renal Response

11

22

31

39

51

29

86

60

11

17.9%

29.5%

15.8%21.4%

41.5%38.2%

46.2%40.6%

Control Voclosporin 23.7 mg BID

AURORA Renal Response by Race

p = 0.005 p = 0.165 p = 0.045 p = 0.054

Asian(N = 109)

White(N = 129)

Black(N = 45)

Mixed*(N = 74)

* Mestizo, Mulato, Other

N= 56 42 3219686153 26

10

22

18

26

12

3

13

9

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AURORA Overall Summary of Adverse Events

Control (N = 178)

N (%)

Voclosporin 23.7 mg BID

(N = 178)N (%)

Any Adverse Event (AE) 158 (88.8) 162 (91.0)

Any Serious Adverse Event (SAE) 38 (21.3) 37 (20.8)

- Serious infection 20 (11.2) 18 (10.1)

Any treatment-related SAE 8 (4.5) 8 (4.5)

Any AE leading to voclosporin/placebo discontinuation 26 (14.6) 20 (11.2)

Death* 5 (2.8) 1 (0.6)

Treatment-related AE leading to death 0 0

Disease-related AE 87 (48.9) 96 (53.9)

Disease-related SAE 16 (9.0) 18 (10.1)

* 2 deaths in control group and 1 death in voclosporin group occurred as a result of AEs starting >30 days after discontinuation of study drug.

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AURORA Overall Summary of Adverse Events by Hispanic Ethnicity

Erase Hispanic Non-HispanicControl

N (%) Voclosporin 23.7 mg BID

N (%) Control

N (%) Voclosporin 23.7 mg BID

N (%)

SAEs 13 ( 22.0) 13 ( 23.2) 24 ( 20.3) 24 ( 19.7)

Serious Infections and Infestations

10 ( 16.9) 4 ( 7.1) 10 ( 8.5) 14 ( 11.5)

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AURORA Study Conclusions

• The positive benefit-risk profile observed in AURORA (n=357) confirms the treatment effect seen in AURA-LV (n=265) when comparing voclosporin 23.7 mg BID in combination with background standard of care versus standard of care alone.

• The odds of achieving Renal Response on voclosporin therapy were 2.65x greater than control, while maintaining a comparable safety profile.

• Hispanic ethnicity and Black race LN patients, often severe and difficult to treat subgroups, also noted improved Renal Response with voclosporin.

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Thank you to the AURORA Study patients, investigators,

coordinators, and staff.